IMDELLTRA (AMG757)

SPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAmgen, Inc

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5551305901
1 KIT in 1 PACKAGE (55513-059-01) * 1 mg in 1 VIAL (55513-103-01) * 7 mL in 1 VIAL (55513-068-01)

Annotations

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "1e7b6163-5d83-42ea-82c9-cf7620cdc782": {
      "match": "brand_token",
      "title": "IMDELLTRA (AMG757) (TARLATAMAB-DLLE) KIT [AMGEN, INC]",
      "spl_version": "5",
      "published_date": "2025-12-04"
    }
  },
  "productid": "55513-059_2e2c9381-efd5-4804-aa85-cff5ee5d10ec",
  "productndc": "55513-059",
  "dosage_form": "KIT",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "IMDELLTRA (AMG757)",
  "active_ingred_unit": null,
  "application_number": "BLA761344",
  "marketing_category": "BLA",
  "nonproprietary_name": "Tarlatamab-dlle",
  "start_marketing_date": "20240516",
  "active_numerator_strength": null
}

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